Executive Summary:
Vers. 3.0 --SEPT. 2003 Revisions Included
This summary represents a
synthesis of statute, regulations, court cases, and administrative
enforcement actions to provide an over-view of the current status of the
law. Detailed exceptions or special requirements are not included unless
they are frequently involved in litigated or administrative actions. The
intellectual position of this paper is that avoidance of citation is the
primary goal, and comments reflect that position. This paper is intended
for educational purposes only and should not be relied upon as a legal
opinion.
Legal opinions should be sought from local counsel familiar with CMS
activities and EMTALA (formerly known as EMTALA). Although this
information is prepared, maintained, and offered as educational material by
Stephen A. Frew JD and Frew Consulting Group, Ltd., no direct legal or
consulting services are available from Stephen A. Frew JD or Frew
Consulting Group, Ltd. after March 1, 2002,
THIS IS A SUMMARY OF
HIGH POINTS ONLY. IT IS NOT A FULL STATEMENT OF EMTALA RESPONSIBILITIES OR
LIABILITIES.
Contents...
HISTORY OF EMTALA:
The COBRA law (Consolidated Omnibus Budget Reconciliation Act --COBRA)
was passed in 1986, with a four-page portion addressing the problem of
"patient dumping" -- denial of care or transfer of patients based on
inability to pay for care. Although motivated by the issue of dumping, the
statute itself is NOT an anti-dumping statute, but a federally mandated
standard of practice for hospitals and physicians. This segment of the law
was originally known as COBRA in medical circles and as EMTALA (Emergency
Medical Treatment and Active Labor Act) in legal proceedings. Over the
years, EMTALA has become the most common name for the statute and rules.
The statute is found at 42 USC 1395dd or Section 1867 of the
Social Security Act. It was amended in 1988 and 1989 to add more stringent
QROvisions regulating on-call physicians in general and the practice of
obstetrics, specifically. Florida passed state legislation which generally
paralleled the act, but inserted state-specific standards which remain in
effect. Texas passed a prototype of the EMTALA law prior to the federal
legislation. California, New Mexico, and a number of other states now have
legislation that attempts to address issues in whole or in part covered by
EMTALA.
In 1994, the Health Care Financing Administration (now CMS) passed
rules and regulations that further defined EMTALA obligations of
hospitals, and imposed certain new requirements. Some of these revisions
left the Florida statute more restrictive in certain aspects than the
federal standard. Other states may also have laws with the same potential
effect.
Greater concern, however, is raised by state laws that impose lesser or
conflicting standards. These laws, while enforced within the jurisdiction,
may violate EMTALA directly -- and are therefore pre-empted by EMTALA -- or
may cause confusion which results in accidental violation of EMTALA.
In 1998, CMS issued new site review guidelines (Available online at
www.medlaw.com/site.htm)These guidelines are general instructions to the
inspectors making the site visit. Although these guidelines were expected
to make a number of "liberal" changes to the rules, this did NOT occur.
The most significant language change added a specific instructions to
site reviewers that hospitals are NOT to make any verification, courtesy,
or pre-authorization calls to payers prior to completion of the medical
screening examination and stabilization. Hospitals that make
pre-authorization calls are deemed in violation of the law. The 2003
revisions to the regulations make pre-authorization calls potentially
possible, but the complications do not appear worth considering them. See
discussion below.
In 1999, new regulations
on patient rights added language about restraint and seclusion which
placed significant restrictions on use of physical and chemical restraint.
These revisions placed heavy restrictions on use of these methods for
control of patient behavior, required physician face-to-face evaluation,
QROhibited PRN orders for restraint (including drugs for management
purposes), and set time limits on orders. These revisions had significant
impact on standards for ED management of psychiatric patients under
EMTALA.
In 2000, CMS issued new regulations for the Out-patient
prospective Payment System (OPPS) which included significant EMTALA
expansion. Specifically, the OPPS require the hospital to provide
emergency response capabilities, beyond merely calling 9-1-1, for
accidents, injuries, or patient presentations on the hospital campus,
which was defined to include a zone of 250 yards surrounding the main
hospital building. In addition, off-site locations were severely
restricted in the OPPS participation for payment, but those areas that do
receive OPPS compensation are required to provide access, medical
screening and appropriate movement of presenting unscheduled patients and
patients/visitors/employees with sudden onset of accident or illness
unrelated to a scheduled visit (or related, but not foreseen). Off-site
locations must also follow the financial rules, signage, and patient care
standards that are required of the Emergency Department under
EMTALA.
Yet another provision of the OPPS regulations requires OPPS
sites and Emergency Departments, and the hospital as a whole to comply
with language translation standards for people with limited English
QROficiency (LEP). These standards impact the requirements for signs,
translation capability, and documentation for compliance with
EMTALA.
In September 2003, CMS issued revised regulations that
restated many prior interpretations that had not yet reached formal
regulatory format, and also clarified and reduced the exposure of off-site
areas for EMTALA compliance. Under the new rules, hospital owned locations
on and off campus were no longer required to have active EMTALA compliance
QROcedures unless they qualified as a "dedicated emergency department."
Dedicated ED's are treatment areas that accept walkin or unscheduled
visits that account for 33.33% of their visits in the prior year as
determined (in retrospect upon investigations being triggered) by CMS
random audit-- OR-- if the name implies emergency services, such as
"Urgent Care" -- OR -- if hospital advertising or signage or otherwise
holds the location out to the public as a place to come for emergency
services or something similar. The hospital remains responsible for
response capability within 250 yards of the hospital to assist persons in
need of care. The new regulations also took the position that they would
not apply EMTALA to patients who had been admitted, but would monitor and
enforce the Medicare Condition of Participation standards against
hospitals if an inpatient violation was detected. An admitted patient is
one that is admitted with the expectation that they will remain
hospitalized in the facility overnight. Patients who are admitted for
stabilization and transfer remain covered by EMTALA, as do those who are
admitted for the purpose of avoid EMTALA, such as an admission and
immediate discharge or admission to avoid responding on-call. How this
change will affect inspections and enforcement will be more clearly
articulated when new site review guidelines are published by CMS.
ENFORCEMENT:
The Centers For Medicare and Medicaid Services (CMS) division of the
Department of Health and Human Services is responsible for investigation
and partially responsible for enforcement of this statute. The Office of
Inspector General (OIG) of the Department of Health and Human Services is
responsible for other enforcement aspects of the law. Violations of EMTALA
also are reported to the Justice Department for evaluation for Hill-Burton
Act violations, to the Office of Civil Rights for evaluation of
discrimination implications, to the Internal Revenue Service for
evaluation of implications for tax-exempt status, and to JCAHO for
accreditation review. All of these agencies are potential enforcers of the
law, but only CMS and OIG are actively involved in most instances.
CMS is not sufficiently staffed to promptly deal with each and
every reported violation and resulting investigation. Some states have
substantial delays of several years in finalizing citations. OIG likewise
often takes years following a citation to finalize administrative civil
monetary penalties (fines).
Private enforcement of the law is provided by creation of a special
civil cause of action against hospitals for violations. This cause of
action can be based on the actions of employees, hospital policies and
procedures, and upon actions of independent physicians on the medical staff
of the hospital. This action may be brought in state or federal court, and
is separate and distinct from any medical malpractice cause of action. The
Plaintiff need not establish any deviation from the standard of care, but
only need prove that they received different treatment than another
patient similarly situated or that a EMTALA requirement was violated.
State malpractice procedures regarding hospitals are pre-empted by EMTALA,
according to the majority rule. There is a split of authority on how state
malpractice procedures for physicians apply when the physician is sued for
malpractice along with the hospital EMTALA claim.
To date, an estimated 1700 hospitals -- or more than 1-in-3 US acute
care hospitals -- have received EMTALA enforcement actions from CMS. The
top EMTALA states are Texas, California, Florida, and Georgia. Virtually
all states have had significant citation activity. Few hospitals have
received actual termination, leading some to suggest that the number of
cases reflect a lack of enforcement and lack of effective sanctions by
CMS. A hospital actually terminated in 1996 for following managed care
procedures, however, has shocked the industry into the realization that
failing to take EMTALA seriously truly can be fatal.
In 1997, a
hospital was other violations of the Conditions of Participation in
Medicare. This hospital did not achieve re-admission to the program for
approximately 7 months. During that time, the hospital had to render care
in compliance with Medicare rules, BUT NOT GET PAID. Upon re-admission, no
back payment is allowed. In this incident it is reported by insiders that
the 40-50 bed hospital lost more than $30 million in reserves to keep the
hospital open.
Again in 2001, a psychiatric hospital in Oklahoma
was terminated from Medicare for EMTALA violations.
Current
literature includes articles on the "over-rated" risk of EMTALA sanctions
by comparing the number of cited cases to the total volume of ED visits to
suggest that it is an insignificant risk. That position, however ignores
the harsh reality of the hospitals that are cited -- including small
hospitals up to "mega" medical centers like Parkland Hospital in Dallas
(cited in 1996). The high ratio of hospitals with citations represents a
severe threat that deserves to be taken seriously by any institution.
The cost of a EMTALA citation -- in terms of internal time
committed to the plan of correction, outside consultants and lawyers, and
the cost of additional equipment or FTE's to support the plan of
correction remedies generally reaches $150,000 in small hospitals and
exceeded $1.8 million in projected costs for one 400 -500 bed facility for
the first year of the plan of correction.
Several hundred EMTALA civil cases have been filed in the US, with
verdicts and settlements reported in excess of $3 million in some cases. A
number of cases have been decided in favor of the involved hospitals prior
to trial. A majority of cases appear to have been settled prior to trial.
The legal environment is still developing, and conflicting rulings are
frequently seen between the federal court circuits. These conflicts are
beginning to be worked out in Courts interpreting the sole Supreme Court
ruling on EMTALA, but the process will necessarily require extended
litigation over as long as three to five years before the Supreme Court
will again be in a position to provide guidance to the conflicting courts.
Possible violations of EMTALA must be reported by receiving
hospitals within 72 of the possible violation, pursuant to 1994
regulations. These regulations were not enforced, due to Paperwork
Reduction Act technicalities, until September 1995. They are now in effect
and carry significant sanctions for non-reporting. This source presents a
majority of cases reaching CMS attention at this time. Other sources
include: physician complaints, patient complaints, EMS system complaints,
routine site visits, newspaper articles, and 1-2 screens. Any possible
violation that comes to state attention must be reported to CMS by the
state. Florida requires any health care professional with knowledge of a
violation to report it to the state within 30 days -- including
self-reporting. Federal law does not require self-reporting.
Upon review and determination that a credible allegation of
violation exists, the regional office of CMS, issues a direction to the
state hospital licensing officials to conduct an unannounced focus survey
to determine the facts associated with the possible violation. The state
is not to disclose the nature of the originating case (index case) nor the
nature of their findings during the investigation. The state is to forward
all information to the regional CMS office for evaluation and
determination of whether a violation has occurred.
If a violation is deemed to have occurred, CMS issues a notice to the
hospital that its Medicare participation will terminate in 23 days, unless
a suitable plan of correction is submitted. These plans must show credible
evidence of current compliance -- i.e. planned steps for future correction
are not acceptable. On day 19 of the process, a notice of termination is
published in local newspapers, unless a suitable plan has been submitted
and re-survey has validated compliance prior to day 19.
If a suitable plan of correction is submitted and validated by
re-survey within the 23 day period, the termination is converted to a 90
day termination track, which provides for a subsequent re-survey to
validate on-going compliance. A hospital may be removed from the
termination process, but left on state observation for a period of time to
further validate the effectiveness of the plan of correction. Upon
clearance all termination or observation conditions, "Deemed" status is
restored.
Physicians found in violation of EMTALA for multiple or flagrant
violations may be terminated from Medicare participation.
Hospitals that fail to report violations by other hospitals may be
terminated from Medicare participation. The first citation against a
hospital for failure to report occurred in 1996. While it is still not a
high-volume citation issue, failure to report remains a concern that
should be appropriately addressed by policies in each facility.
Considerable variation exists in the standards applied to specific
situations in various regions of CMS, and among various states within a
region. This is primarily a factor of confusion or internal policy
differences among system participants.
In the event that CMS
determines the Conditions of Participation (COP's) have been violated at a
serious level, the hospital may also face termination from Medicare. This
process, however, typically allows hospitals a longer period to remedy
violations and is usually less confrontational and Draconian than an
EMTALA citation. Please be aware, however, that it is not a pleasant
process and is very demanding -- it is potentially fatal to the hospital
just like EMTALA citations -- and the only "good" thing about it is the
greater time to address issues (but they still have to be addressed). In a
CoP investigation, every minute detail of hospital operation is under
scrutiny, rather than just those related to EMTALA, and it is not to be
under-estimated for ignored.
The OIG operates separate
from CMS, but receives the CMS findings and evaluations from the Draconian, and
determines whether it can QROve a violation occurred. If so, it issues a
notice of civil monetary penalty (CMP)-- i.e. fine. The CMP may be up to
$50,000 per violation (not per patient) for hospitals of 100 beds or more;
$25,000 per violation for hospitals of 99 beds or less; and $50,000 per
violation per physician. CMP's are not covered by malpractice insurance.
The largest fine to date for a hospital is $350,000.
The largest fine to date for a physician is $100,000 for a surgeon
who transferred two patients without performing surgery to stabilize the
patients, failing to obtain advance acceptance of the patients and failing
to comply with documentation standards of compliance. While that case was
subsequently reversed for an administrative issue and a court position
unique to that circuit (6th Circuit), it does represent an indicator of
CMS policy on physician fines -- they intend to issue them and hold physicians responsible for transfer decisions that do not comply with the agency's standards for EMTALA compliance.
The organization functions as a
non-binding advisor to the OIG on whether EMTALA violations can be proven. The QIO reviews do NOT affect the CMS termination procedures unless CMS specifically defers action pending QIO review. Generally, CMS actions are completed and findings submitted before QIO review commences. QIO reviews tend to be more
influenced by standard medical practice than the requirements of EMTALA,
and often find no violations in cases that CMS and the courts have
determined violations exist. Considerable tension exists between state
QRO's and CMS offices over EMTALA enforcement standards. This discrepancy
can be helpful to hospitals faced with OIG fine actions, to lower their
over-all exposure to fines.
The new regulations seem to signal an increased expectation that the CMS actions will be based on at least a 5-day emergency review by the QIO.
State
enforcement agencies have varying degrees of familiarity with EMTALA and
tend to be heavily influenced initially by their own experience in the way
hospitals operate in their own environment. As state agencies get more
experience dealing with CMS expectations, the strictness of EMTALA
enforcement standards increases. State agencies are severely stressed by
the short time frame (5 days) provided by regulations for completion of
EMTALA investigations, and some states have been forced to completely
cease state-based inspections in order to comply with demands for various
types of federal inspections, including EMTALA.
No pre-termination
appeals rights exist under EMTALA. A hospital is faced with the choice of
submitting a plan of correction in the time provided or going to
termination, and then appealing. During the appeals QROcess, no Medicare
benefits are paid to the hospital. No right exists to obtain an injunction
to block the termination pending appeal. The appeal QROcess includes a
hearing before an administrative law judge, and from there an appeal to
the national appeals board, and from there a direct appeal to the US
Circuit Court of Appeals for the jurisdiction in which the hospital is
located. The appeals QROcess takes up to three years, and it is generally
conceded that bankruptcy will close a hospital long before its appeals
QROcess is completed. No determination has been made whether a Chapter 11
bankruptcy filing by a hospital would stay the termination of benefits,
but neither does any facility want to be the test case to evaluate this
route of EMTALA defense. Negative publicity associated with the
termination is considered to be potentially fatal in-and-of-itself.
Hospitals
which receive Medicare benefits are required to:
1. Provide a medical screening examination to all patients that
present upon its premises. This provision, as interpreted and applied,
requires hospitals to accept and evaluate any patient on its premises who
presents for a non-scheduled visit and seeks care, regardless of ability
to pay. The scope of the medical screening exam will be discussed later,
but is extensive and triage does not meet the screening requirement.
Hospital premises includes hospital-owned and operated ambulances and
off-campus locations billing under the same Medicare provider number and
areas, facilities or services contained in the hospital's operating
certificate --i.e. hospital-owned clinics or physician practices owned by
the hospital. Those units that are under the legal definition of a
dedicated emergency room are fully bound by EMTALA, while those that are
not are required to have policies and procedures on how the unit is to
respond to a patient presenting with what a prudent lay person would
consider to be a condition requiring immediate assessment and care.
The 2003 exceptions for MSE patients presenting on hospital
property are:
- Admitted patients
- Patients who experience problems after commencement of scheduled
out-patient procedures
- Patients who are on premises for purposes other than an ED visit,
such as BP screening at a health fair (unless they experience a medical
crisis on premises)
- Scheduled out-patient and return visits (still requires logging and
some medical documentation) and
- Ambulances with patients on the hospital property for the sole
purpose of meeting a helicopter at the helipad for transport to another
destination, so long as the ambulance or helicopter does not request
medical assistance in the managing of the patient.
2.
Provide stabilizing care. Stability under EMTALA requires a much
higher level of patient condition than that typically connoted by the word
"stable" in usual medical usage. It requires that a pregnant female
experiencing contractions is not legally stable until the baby and
placenta are delivered. It also requires that in non-maternity cases the
hospital must assure that patient is not reasonably at risk to deteriorate
from, during, or following transfer or discharge. If the patient is
reasonably at risk to deteriorate from the natural QROcess of their
condition, they are legally unstable under this standard, just as if the
transfer or discharge itself caused the deterioration. Courts have
determined that EMTALA applies to in-house patients as well as emergency
department patients, while CMS enforces EMTALA primarily in cases of ED
admissions that are not yet stabilized when they are transferred or
discharged.
3. Not transfer patients who are potentially unstable if the
hospital has the capabilities and the physical capacity to treat the
patient. Patients may only be transferred under EMTALA for medical
necessity. Physician convenience or practice preferences are not
permissible reasons for transfer. Florida requires hospitals to establish
formal statements of their capabilities and are held to these capabilities
for EMTALA compliance purposes.
Under EMTALA, a transfer is defined as any time the patient leaves
the campus of the hospital, including discharge, unless AMA or deceased.
4. Maintain an on-call system to provide coverage to be
available to assist stabilizing patients. The 2003 regulations
indicate that CMS will hold hospital responsible to meet the needs of
their patient population. The hospital must have a call list and may
maintain it in the manner it deems appropriate, but it will be up to the
CMS surveyor as to whether the call system, scope of the list vis. the
specialties on-call, physician compliance, and enforcement of the list
against resisting physicians has been adequate. The wording of the
regulation has changed, but CMS has stated in the regulations that it does
not intend that a change in the expectations of coverage have changed. A
named individual physician (and not a group or call service) must be
listed on the list and held responsible for call at a given time in a
given specialty, and that call list must be conspicuously posted in the ED
at all times. An accurate record of each on-call list must be maintained
for 5 years. On-call physicians must respond to the hospital and render
evaluation and care in the hospital -- it is not permissible to send
patients to a specialist's office for definitive care.
The
comments in the 2003 regulations now make it permissible for a physician
assistant or nurse practitioner to respond for the on-call physician under
limited circumstances: 1) The physician is the one listed as on-call 2)
The on-call physician after being fully apprised of the patient's
condition determines that the response is appropriate for a PA or NP and
3) The Emergency Physician or qualified medical person with the patient
concurs. Where specialty assessment should have been provided by the
physician in the opinion of the CMS regional office, but is provided by
the PA or NP, CMS will cite all involved for an EMTALA violation. Standard
or automatic response by the PA or NP in lieu of the on-call physician is
also not permitted. Where the request for specialist response is for
evaluation rather than a procedure (such as casting), it is unlikely that
CMS will accept mid-level providers in lieu of the specialist. No cases
have arisen under this provision as yet, so exact CMS enforcement scope
remains to be seen.
If it is necessary to transfer a patient because an on-call
physician improperly failed or refused to come in, the Emergency Physician
must list the name and address of the on-call physician in the transfer
documentation. This results in the receiving hospital reporting the
incident for EMTALA investigation, with the resulting likelihood that the
hospital and on-call physician will be cited for EMTALA violation. Failure
to list the name is a specific violation which may result in hospital, ED
physician, and on-call physician being cited.
A physician may be
on-call at more than one hospital at the same time if the hospitals are
aware of it and specifically have policies and procedures to cover the
situation if the physician is not available due to prior commitment to a
case at the other facility. The on-call physician may also schedule
surgeries or appointments while on call, with the same limitation. Being
actually engaged in surgery or actively managing a patient who cannot be
left is a bona fide excuse for being unable to respond, but having
patients in the office or having non-emergency surgery scheduled that
would be interrupted by having to respond is NOT AN EXCUSE
under CMS standards. A physician who is on-call at hospital A, but
presently seeing a patient at hospital B or having scheduled surgery at
hospital B may not have the patient at hospital A transferred to B for his
or her convenience, but must respond to hospital A.
Some hospitals
exempt "senior staff" from call. This provision is not an automatic
violation of EMTALA, and is permitted so long as it does not impair the
hospital's ability to staff call. If it does result in uncovered call
time, it is likely to be viewed as unacceptable and an EMTALA violation,
based on past citations.
5. Provide medically appropriate transfers where the patient is
transferred for medically necessity. This process requires:
A. Physician certification that at the time of transfer, the
risks of transfer are outweighed by the reasonably anticipated benefits.
Specific individual risks and benefits must be listed and the record must
support them; OR
B. Written request for transfer by the patient, without
suggestion or pressure of the hospital or physician to induce the request.
In addition, it requires:
C. Advanced acceptance by the destination hospital, which is
documented in the record;
D. Written consent to transfer from the patient;
E. Transfer by appropriate medical transfer vehicle -- i.e.
private passenger vehicles are not permitted unless ambulance transport
has been refused in writing;
F. Medical orders for appropriate attendant personnel --
i.e. must have the licensure and skill level to maintain and/or
initiate/re-initiate ordered treatment or drugs and deal with the known
potential adverse affects of the QROcedures or drugs;
G. Medical orders for appropriate life support equipment -- i.e.
field ambulance equipment may not be sufficient for a specific transfer;
H. Copies of medical records, tests, and x-rays must be sent
with the patient, unless delay for records might jeopardize the patient,
in which case records must be transported to the receiving hospital as
soon as completed and on a STAT basis.
6. Accept requests for in-coming transfer if the
hospital has the specialized capabilities needed by the patient, and the
transferring hospital is relatively less able to care for the patient. The
hospital may decline a patient who does not need the services of the
facility, who can be adequately and completely cared for at the
originating facility, or when the hospital lacks the physical capacity to
handle the patient. Hospitals are at great risk, if they decline a
transfer. Where the hospital has the ability to utilize on-call personnel,
it must do so to accommodate the patient. Where the hospital has handled
patients in excess of its stated capacity on prior occasions, it is
required to accept the patient. Where the hospital could use step-down
beds or early discharge to accommodate a patient, it must do so. Patients
must be accepted without regard to means or ability to pay, or the
third-party payer involved.
Although CMS considers admitted
patient to be outside the bounds of EMTALA for transfer purposes, the
comments to the regulations emphasized that hospitals are still required
to accept the admitted patient in need of a higher level of care where
they would be considered EMTALA patients if they were still in the ED.
From a risk management point of view, all inter hospital transfers
should follow the EMTALA definition of anappropriatee transfer process,
as it is highly likely that CMS will follow its own definition of what an
appropriate transfer is when enforcing CoP's as well as EMTALA. Likewise,
it would be very difficult to explain to a jury why appropriate standards
for emergency department patients with the same condition are different
from admitted patients with the identical condition. This is a standard of
care issue that is very difficult to respond to. By following the same
protocol for allinter hospitall transfers, you achieve standardization and
compliance levels of documentation for EMTALA, CoP's and malpractice
defense purposes simultaneously. We consider this to be the best practice
for transfers.
The
scope of medical screening exams (MSE) under EMTALA is to provide a
medical exam of sufficient scope as to reasonably be intended to determine
whether an emergency medical condition exists, and includes all necessary
testing and on-call services within the capability of the hospital to
reach a diagnosis that excludes the presence of legally defined EMC's. The
term EMC will be defined below. Exams that are "complaint based" and fail
to address affected and potentially affected systems and known chronic
conditions have been held inadequate by CMS.
Florida law also requires the exam to include all necessary
treatment and surgery.
Federal law basically requires all necessary definitive treatment
to be rendered and that only true follow-up care (maintenance care) may be
referred to physician offices or clinics.
Triage of patients is NOT a Medical Screening Exam
and is
NOT an acceptable substitute under EMTALA.
Screening of psychiatric patients must be sufficient to
rule out underlying trauma, disease or organic condition that might have
caused or contributed to the presenting symptoms.
Screening of intoxicated individuals must be sufficient to rule out
medical, toxic, psychiatric, and trauma causes for the apparent
state.
Use of non-physician medical screening personnel is
discouraged but not QROhibited. Screeners must have the capability to
order tests and diagnose to meet the screening criteria. Specific actions
are required to authorize non-physician screening, and CMS does not have
to accept screening plans set up under the criteria for non-physician
screening in individual cases -- i.e. the system will be judged
retrospectively in each case.
Based upon past citations by CMS, advisory letters from CMS, and
past litigation, it is our considered opinion that a medical screening
examination should contain the following elements:
- Log entry with disposition
- Triage record
- On-going vitals recorded
- Oral history
- Physical exam of affected systems
- Physical exam of potentially affected systems and known chronic
conditions
- Any testing necessary to rule out the presence of legally defined
emergency medical conditions
- Use of on-call personnel PRN to complete above
- Use of on-call physicians PRN to diagnose and stabilize patient
- Resolution of abnormal findings or test results by normalization
(serial values) or explanation of why they are not significant to the
presentation
- Discharge/transfer vitals
- Adequate documentation of all above
We recommend against the
use of non-physicians for emergency department medical screening
examinations. We urge the use of objective clinical criteria and scoring
systems for OB screening in the Labor and Delivery department if nursing
staff are to perform OB evaluations as they have historically done in much
of the US.
CMS written standards for designation for a non-physician
for MSE and transfer decisions are items 1 and 2, while the remainder are
those that have been articulated in various citations and should be
considered "critical concerns" when a CMS review is undertaken:
- The classification for qualified medical personnel other than a
physician who is authorized to perform a medical screening exam in
specified departments of the hospital has been approved by the board of
the hospital directly or by Board ratification of Medical Staff Bylaws
provisions. (The concept is that the Board is privileging a
non-physician to perform and extended role, much as a mid-level
provider.)
- The scope of designation must be within the scope of practice for
the designated provider under state laws
- Job description for the role, qualifications, and competencies must
be established
- Formal designation for approved individuals is contained in their
personnel records along with proof of specific EMTALA training
appropriate to their role
- On-going documentation of competencies, qualifications, and quality
review appears in the personnel records of designated individuals
- A written protocol exists defining the authorized functions of the
non-physician
- The protocol must clearly define the point when a patient is
considered beyond the non-physician's capabilities and a physician must
complete the CME
- The rules must provide that the physician backing up the
non-physician doing the MSE is readily available and is mandated to
promptly respond to provide the MSE upon call or
request.
Discharge vitals and adequate discharge summary
are necessary to support a discharge. Un addressed complaints, unresolved
abnormal findings, and undocumented or illegible discharge instructions
are likely to be cited. Full transfer documentation must support a
transfer and justify the transfer under EMTALA.
Criteria for non-physician (qualified medical person
--QMP)
The
term EMC is much broader under EMTALA than under typical medical usage.
This is a significant underlying cause for many EMTALA violations. The
term includes any condition that is a danger to the health and safety of
the patient or unborn fetus; or may result in a risk of impairment or
dysfunction to the smallest bodily organ or part if not treated in the
foreseeable future; and includes a specific range of itemized conditions:
- . Undiagnosed, acute pain sufficient to impair normal functioning is
an EMC [Editorial comment: pain scale of 7 or greater is commonly
associated with this level of impaired function, but this will be judged
retrospectively by CMS based on patient version and outcome, so
documentation is critical. A lower pain value may not be "safe"];
- Pregnancy with contractions present is an EMC -- i.e. legally
defined as unstable;
- Symptoms of substance abuse -- i.e. alcohol ingestion;
- Psychiatric disturbances -- i.e. severe depression, insomnia,
suicide attempt or ideation, dis-associative state, inability to
comprehend danger or to care for one's self.
Federal law permits the obtaining of information in the
routine registration QROcess, but the information may not be acted on --
i.e. no advance approval may be obtained from a third-party payer or
employer.
Calls to insurance companies or employers have repeated resulted in
citations for EMTALA violation. Handing a phone to the patient and having
them call their insurance has likewise resulted in citations. CMS
specifically states that third-party payers do not have the authority to
authorize treatment and that hospitals that follow HMO and insurance
company procedures and directions will be cited for EMTALA
violations.
Patient transfers decisions may not be based on HMO/PPO
direction or policy.
CMS 2003 regulations strongly endorse the
OIG/CMS prior "best practices" (translate that to "what we expect...") but
do allow some slightly wider latitude. The basics of the "best practices"
are:
- Name and one other identifier at triage
- Patients who are not triaged to the back my have routine
registration that does not discourage the patient from completing care
(Comment: If you have a conditions of admission form with guarantors,
personal liability statement, and assignment of benefits, you are at
risk for financial discussions and resulting patient departures. CMS has
indicated that any system that induces departures will be at risk for
citation for violating EMTALA.)
- You MAY ask for insurance information and copy the card
- You are strongly DISCOURAGED from any financial discussions at this
point
- If the patient asks about financial issues, you are to say that
finances can be dealt with following care
- If the patient continues to insist, the best practices indicate that
a financial person experienced in EMTALA should hold that conversation
(Comment: I strongly recommend that physicians and nurses NOT DISCUSS
any financial issues with the patient at any time)
- You may contact a physician for medical purposes at any time, but
not for gatekeeper permission to treat (Comment: private physicians
should be contacted only where there is a documented medical need, and
no request by the PCP to send the patient to the office should be
granted.)
- You may contact the insurance company after care is initiated
(although most now do not require that), but if permission to treat or
admit is DENIED, you still must provide the care. (So why
call?)
- It is not required, but is considered a prudent approach, to
separate the financial face sheet from the treatment record, so the
treating physician is not aware of denials or types of insurance.
- Once the patient has had an MSE and is stabilized and/or admitted or
the patient is determined not to have any emergency medical condition
under the law, completion of registration and financial discussions may
occur without EMTALA restrictions.
Standing systems, such
as trauma center programs do not exempt participating hospitals from
EMTALA compliance, although certain Regional Offices are more flexible
with community-based plans for services than others. The 1998 guidelines
indicate that community plans may justify original diversion in the field,
but once the patient arrives at a hospital, that hospital must screen and
stabilize before transfer, if able within its capabilities and services.
Transfer certification, acceptance, transfer consent, and medical records
documentation is required in every region.
Diversion of ambulances
is only permitted following a community-wide plan to assure that decisions
on acceptance of ambulances is based on true capacity and capabilities
rather than selective patient practices. The 2003 modifications added the
concept that EMTALA compliance on issues of care and diversion will not be
cited during declared national emergencies. It seems doubtful that the
absence of a declaration of emergency will be forthcoming until after the
fact, so this basically leaves the hospital in the position of having to
take it on faith that CMS will not cite for following a community disaster
plan when a hospital has actually activated their disaster plan -- I
cannot be certain, but I think this is about 99.9% probable, based on past
actions by CMS. Hospital-owned ambulances are required to transport
patients to the owner hospital for similar reasons. The 2003 regulations,
however, have articulated some exceptions to that provision --
hospital-owned ambulances are exempt from this when:
- The ambulance is following a community-wide EMS plan --or
- The ambulance is operating under EMS protocols developed by the
system medical director, if the medical director is not an employee or
affiliated with the owner-hospital -- or
- Upon documented patient informed request to go elsewhere
State waivers for Medicaid do not waive EMTALA. Many waiver states have
adopted managed care and gate-keeper models to discourage emergency
department use. Compliance with these systems has resulted in significant
enforcement action against hospitals in the past year under EMTALA., The
1997 Balance Budget Act bans Medicaid and Medicare managed care plans from
requiring pre-authorization.
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